American Pharmaceutical News In Review

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January 13, 2021

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	Industry News

FDA Grants Advaite Emergency Use Authorization FOR RapCov Rapid COVID-19 Test
The FDA has granted EUA to one of the first U.S.-manufactured serology tests designed by ADVAITE. read more »

Precision Dose Recalls Paroex Chlorhexidine Gluconate Oral Rinse
Precision Dose is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, ... read more »

Radius Health Announces Commercial Agreement with Paladin Labs for Abaloparatide in Canada
Radius Health has entered into definitive agreements with Endo Ventures Limited to register, ... read more »

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID... read more »

Precigen Announces IND to Begin Study of AdenoVerse Immunotherapy for RRP
Precigen announced that the FDA has cleared the IND application to initiate a trial of PRGN-2012, an... read more »

Inhibrx Announces Phase 1 Dose Escalation Results of Novel Hexavalent OX40 Agonist
Inhibrx has announced results from Part 1 of the Phase 1 dose escalation trial of INBRX-106, a novel... read more »

	QC Corner

The Human Microbiome: What It Is, Why It Is Important and Opportunities for Microbiome-Based Therapeutics
The human body is home to a huge and diverse community of microorganisms, consisting of bacteria, ... read more »

Filing a Multistage Continuous Process for API
In recent decades, the pharmaceutical industry has witnessed a revolution in the regulatory ... read more »

	Infographic

How to Maximize Viral Clearance in a Membrane-Based Process
Product safety is a big concern in biopharmaceutical manufacturing. Specifically, virus contamination in biopharmaceutical products is critical to ... read more »

	Featured Articles

QC Corner: Overcoming the manufacturing bottleneck caused by bioburden testing To ensure that a pharmaceutical product is safe for patients, it is mandatory to determine its bioburden in a tightly regulated quality control ... read more »

Test Your Readiness for New ICH M10 Reporting Requirements As 2020 comes to a close, drug development companies await the finalization and implementation of the ICH M10 guidance. The M10 guidance from the ... read more »

	Featured Video

On-Demand Webinar: Continuous Improvement – Using a Handheld Raman Spectrometer for Quality Testing in Biopharmaceutical Manufacturing
In this webinar, you’ll learn what TruScan is and how it supports continuous improvement for biopharma manufacturers, applications using TruTools ... watch »

On-Demand Webinar: Dodge the Particle Panic: Visible and Subvisible ID Made Easy with Raman Spectroscopy and LIBS
In this webinar, Dr. Robin Sweeney will demonstrate how new hardware and software advances have made it even simpler to use Hound for identifying ... watch »

	Featured Products

Sterile PeridoxRTU® Sporicidal Disinfectant
read more »

Cellicon™ Perfusion Solution
read more »

	Featured Whitepaper

eBook: TOC and Microbial Detection Monitoring
Proper and thorough monitoring of pharmaceutical water systems is imperative to deliver the highest quality products to patients. read more »

New Data to Support Activation Test for pyrogen detection Detect both endotoxin and non-endotoxin pyrogens in a single in vitro assay
Wondering how suitable a cell line-based Monocyte Activation Test is for detecting pyrogens? read more »

	Events

Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection
Online – 01/26/2021
For the last several years, Bionique Testing Laboratories has been in a unique position to facilitate the adoption of rapid mycoplasma testing ... event details »

Excipient World 2021
National Harbor, MD – 09/27/2021
Excipient World is the leading education, networking and sourcing resource for the $6+ billion and growing global excipient market. It’s the ONLY U.S.... event details »

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